欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SK/H/0126/001
药品名称Qualis 25 mg film-coated tablets
活性成分
    • quetiapine fumarate 28.78 mg
剂型Film-coated tablet
上市许可持有人Alapis S.A. Aftokratoros Nikolaou str., 2 17671 Athens Greece
参考成员国 - 产品名称Slovakia (SK)
Qualis 25 mg filmom obalené tablety
互认成员国 - 产品名称
    • Greece (GR)
    • Bulgaria (BG)
      Quetiapine Alapis
    • Cyprus (CY)
      QUETIAPINE ALAPIS 25mg FC TABS
    • Romania (RO)
      Quetiapina Alapis 25 mg comprimate filmate
许可日期2010/12/22
最近更新日期2014/06/02
药物ATC编码
    • N05AH04 quetiapine
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Multiple (Copy) Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
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